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` MARK J. RATAIN, M.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC., )
`BRECKENRIDGE )
`PHARMACEUTICAL, INC., and )
`ROXANE LABORATORIES, INC., )
` )
` Petitioners, )
` )
` vs. ) Case IPR2016-00084
` ) U.S. Patent No.
`NOVARTIS AG, ) 5,665,772
` )
` Patent Owner. )
`
` DEPOSITION OF MARK J. RATAIN, M.D.
` Chicago, Illinois
` Friday, December 16, 2016
`
`Reported by:
`JANET L. ROBBINS, CSR, RPR
`JOB NO. 116752
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 1 of 8
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`Page 1
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` MARK J. RATAIN, M.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC., )
`BRECKENRIDGE )
`PHARMACEUTICAL, INC., and )
`ROXANE LABORATORIES, INC., )
` )
` Petitioners, )
` )
` vs. ) Case IPR2016-00084
` ) U.S. Patent No.
`NOVARTIS AG, ) 5,665,772
` )
` Patent Owner. )
`
` DEPOSITION OF MARK J. RATAIN, M.D.
` Chicago, Illinois
` Friday, December 16, 2016
`
`Reported by:
`JANET L. ROBBINS, CSR, RPR
`JOB NO. 116752
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 1 of 8
`
`
`
` MARK J. RATAIN, M.D.
`
`Page 2
`
` December 16, 2016
` 9:31 a.m.
`
` Deposition of MARK J. RATAIN, M.D., at
`330 North Wabash Avenue, Suite 2800, Chicago,
`Illinois, pursuant to notice, before JANET L.
`ROBBINS, Illinois Certified Shorthand Reporter,
`Registered Professional Reporter.
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 2 of 8
`
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`Page 3
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` MARK J. RATAIN, M.D.
`A P P E A R A N C E S:
`LATHAM & WATKINS
`BY: JONATHAN STRANG, ESQ.
`555 Eleventh Street, NW
`Washington, DC 20004
` appeared on behalf of Par
` Pharmaceutical, Inc.;
`
`FITZPATRICK, CELLA, HARPER & SCINTO
`BY: CHARLOTTE JACOBSEN, ESQ.
`SUSANNE FLANDERS, ESQ.
`1290 Avenue of the Americas
`New York, New York 10104
` appeared on behalf of Novartis AG
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 3 of 8
`
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`Page 4
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` MARK J. RATAIN, M.D.
` I N D E X
`WITNESS:
`MARK J. RATAIN, M.D.
`
` PAGE
`EXAM BY MS. JACOBSEN 5
`EXAM BY MR. STRANG 217
`
` E X H I B I T S
`IPR DESCRIPTION PG LN
`Exhibit 2220 Dose-Escalating Study 37 3
` of Capecitabine Plus
` Gemcitabine
` Combination Therapy
` in Patients with
` Advanced Cancer by R.
` Schilsky, et al.
`Exhibit 2221 Phase II Oncology 95 11
` Trials: Let's Be
` Positive by Mark J.
` Ratain
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 4 of 8
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` MARK J. RATAIN, M.D.
` (Witness sworn.)
` MARK J. RATAIN, M.D.,
`called as a witness herein, having been first
`duly sworn, was examined and testified as
`follows:
` EXAMINATION
`BY MS. JACOBSEN:
` Q. Good morning, Dr. Ratain. 09:31
` A. Good morning. 09:31
` Q. Now, I know you've been deposed 09:31
`before, and so there's not a great deal of need 09:31
`to go over the ground rules. 09:31
` But just so that we have a clean 09:31
`record as before, I ask that you wait until I 09:31
`finish my question before you answer, and I 09:31
`will try to do the same with respect to your 09:31
`answers. 09:31
` Is that okay? 09:31
` A. Yes. 09:31
` Q. And if you don't understand any of 09:31
`my questions, please ask me to rephrase them or 09:31
`to clarify the terms that you don't understand. 09:31
` Can you do that? 09:32
` A. I assume you mean if I don't 09:32
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 5 of 8
`
`
`
`Page 119
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` MARK J. RATAIN, M.D.
`ratios for various patient populations." 12:23
` Do you see that? 12:23
` MR. STRANG: Objection to scope. 12:23
` THE WITNESS: I see that. 12:23
`BY MS. JACOBSEN: 12:23
` Q. So at least this references drawing 12:23
`a distinction between activity, which is 12:23
`Objective 3, and effectiveness, which is 12:23
`Objective 4, is that fair? 12:23
` MR. STRANG: Objection to scope. 12:23
` THE WITNESS: Well, I think 12:23
` effectiveness is different than efficacy. 12:23
` So effectiveness is when you give a drug to 12:23
` large populations, does it work? 12:23
` Efficacy and activity are used 12:23
` interchangeably, and I don't distinguish 12:24
` activity and efficacy. 12:24
` A summary of efficacy could be 12:24
` considered a measure of effectiveness, but 12:24
` effectiveness has a distinct meaning from 12:24
` efficacy. 12:24
`BY MS. JACOBSEN: 12:24
` Q. And what does "effectiveness" mean? 12:24
` A. It means if you want to give a drug 12:24
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 6 of 8
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` MARK J. RATAIN, M.D.
`to large populations, will it work? 12:24
` Q. And that is a distinct concept from 12:24
`activity? 12:24
` A. It is a distinct concept from 12:24
`activity. 12:24
` Q. Okay. 12:24
` A. I mean, a drug may be active, but it 12:24
`may be too toxic to be effective, for example. 12:24
` Q. Okay. And when you talk about 12:24
`activity and efficacy in your expert 12:24
`declaration, you're talking about activity 12:24
`rather than effectiveness? 12:24
` A. That is correct, because 12:24
`effectiveness requires -- to demonstrate 12:24
`effectiveness, you really need Phase III 12:24
`randomized trials. 12:25
` Q. And then let's turn to Page 507. 12:25
`And there's a section that's entitled 12:25
`"Label-Driven Question-Based Clinical 12:25
`Development Plan Paradigm." 12:25
` Do you see that? 12:25
` A. I do. 12:25
` MR. STRANG: Objection, scope. 12:25
` ///
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 7 of 8
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` MARK J. RATAIN, M.D.
` trial was that was done with everolimus. 13:21
` Bolero or something? 13:21
`BY MS. JACOBSEN: 13:21
` Q. No, that's the breast cancer one. 13:21
` A. All right. Whatever the trial that 13:21
`was done in PNET, whatever the name of that 13:21
`trial was, I have those data. 13:21
` If I ignored the placebo patients 13:21
`and just focused on the patients treated with 13:21
`everolimus and only counted responses, I would 13:21
`say the response rate is 4.8 percent. That's 13:21
`not very good. It's not a very good drug. 13:21
`It's not worth pursuing. 13:21
` Q. All right. And that's because 13:21
`everolimus or mTOR inhibitors are not agents 13:22
`where you would expect to see a high response 13:22
`rate, is that correct? 13:22
` A. That's correct. 13:22
` Q. And the Phase II trial that we've 13:22
`been talking about, the Duran temsirolimus 13:22
`trial, that's not a trial that demonstrates 13:22
`effectiveness as we spoke about it before 13:22
`lunch, is that correct? 13:22
` A. That's correct. 13:22
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2106
`Par v. Novartis, IPR2016-01479
`Page 8 of 8
`
`
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